Study for reduction of Eye Pressure

• Register: CTRI
• Last refreshed on: 17 October 2022
• Main ID: CTRI/2018/02/012240
• Date of registration: 28-02-2018
• Prospective Registration: No
• Primary sponsor: iSTAR Medical SA
• Public title: Study for reduction of Eye Pressure
• Scientific title: A Prospective, Open, Multicenter Clinical Trial analyzing the Effectiveness and Safety of MINIject-636 in Patients with Open Angle Glaucoma uncontrolled by Topical Hypotensive Medications
• Date of first enrolment: 29-11-2017
• Target sample size: 50
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=20577
• Study type: Interventional
• Study design: Single Arm Study; Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
• Phase: N/A

Countries of recruitment

Colombia, India, Panama

Contacts

• Name: Mr Naresh Kumar Pagidimarry
• Affiliation: Maxivision Super Speciality Eye Hospital

• Name: Dr Kasu Prasad Reddy
• Affiliation: Maxivision Super Speciality Eye Hospital

Key inclusion & exclusion criteria

Inclusion criteria: 1. Males or females, 18 years of age or older.



2. Diagnosis of primary or secondary open angle glaucoma during screening/baseline visit or earlier.



3. Grade 3 (open, 20-35 degrees) or grade 4 (wide open, 35-45 degrees) according to Shaffer Angle Grading System.



4. Glaucoma not adequately controlled by one to four different topical hypotensive medication(s), given each for at least one month, as confirmed by 21 mmHg � IOP � 35 mmHg in the study eye at screening and baseline visits.



5. Patient must be willing and able to return for scheduled study-related examinations.



6. Patient must provide written informed consent.


Exclusion criteria: 1. Diagnosis of glaucoma other than open angle glaucoma (e.g. angle closure glaucoma) in the study eye.



2. Grade 2 (narrow, 20 degrees), grade 1 (extremely narrow, less or equal to 10 degrees) and grade 0 (closed or slit) according to Shaffer Angle Grading System.



3. Neovascular glaucoma in the study eye.



4. Corneal opacity or iridocorneal angle not visible through gonioprism in the study eye, preventing correct placement of the implant.



5. Prior eye surgery in the study eye within 90 days before screening visit.



6. Prior glaucoma surgery in the study eye, except patient treated with argon laser trabeculoplasty or selective laser trabeculoplasty in the study eye may be eligible if treatment performed � 90 days before screening visit.



7. Visual field defect in the 10 degree central field in the study eye.



8. Anticipated need for ocular surgery or retinal laser procedure in the study eye in the 12 months following surgery.



9. Anterior chamber anatomic configuration of high risk for development of angle closure glaucoma in the study eye.



10. Clinically significant corneal disease (e.g., corneal dystrophy) in the study eye.



11. Pre-existing ocular or systemic pathology that, in the opinion of the physician, is likely to cause postoperative complications following implantation of the device in the study eye.



12. Evidence of crystalline lens subluxation or luxation in the study eye.



13. Evidence of vitreous loss in the anterior chamber in the study eye.



14. Clinically significant intra-ocular inflammation or infection, presence of ocular disease such as uveitis, ocular infection, severe dry eye, severe blepharitis, active proliferative/inflammatory retinopathy in the study eye.



15. Presence of silicone oil in the study eye.



16. Patients treated with systemic acetazolamide within 3 days before screening visit.



17. Patients with poor vision (LogMAR score: +1.0) in non-study eye, unless there is an expected benefit for the study eye, in the opinion of the investigator.



18. Participation in any study involving an investigational drug or device within the past 3 Months.



19. Only for women of childbearing potential: positive urine pregnancy test at screening.



20. Individuals under tutorship or trusteeship.



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Patients with Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications

Intervention(s)

Intervention1: MINIject-636: MINIject-636 is an integrated system comprising a minimally-invasive Glaucoma Drainage Implant and a Delivery Tool. Patients will be followed up for 24 months
Control Intervention1: Nil: Nil
Control Intervention2: Nil: Nil
Control Intervention3: Nil: Nil

Primary Outcome(s)

Reduction in medicated mean diurnal IOP at 6 months follow-up compared to medicated diurnal IOP at screening visitTimepoint: 6 Months

Secondary Outcome(s)

Absolute and relative reduction (in %) of medicated diurnal IOP compared to medicated diurnal IOP at screening visit.Timepoint: Day 1, Week 1, Week 2, Month 1, Month 3, Month 6, Month 12, Month 18, Month 24

Secondary ID(s)

2018/ISM05/AM1 Version 2.0 dated March 30, 2018

Source(s) of Monetary Support

iSTAR Medical SA Avenue Sabin 6, 1300 Wavre, Belgium

Ethics review

Status: Approved
Approval date: 25/11/2017
Contact:

STAR Institutional Ethics Committee

Status: Approved
Approval date: 01/05/2018
Contact:

STAR Institutional Ethics Committee

Results

• Date Completed: 10/01/2022